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Drugs and Medicinal Substances

Tabelecleucel

Antineoplastic and Immunomodulating Agents

Tabelecleucel, sold under the brand name Ebvallo, is a medication used to treat Epstein-Barr virus positive post-transplant lymphoproliferative disease. It is an allogeneic, Epstein-Barr virus specific T-cell immunotherapy, made from donor T-cells selected to recognize and destroy cells infected with the Epstein-Barr virus in a manner restricted by the patient's tissue type. Post-transplant lymphoproliferative disease is a cancer-like overgrowth of lymphoid cells that can occur in some organ transplant recipients because of the immunosuppressive medication they take to prevent organ rejection. It is indicated for patients aged two years and older with relapsed or refractory disease who have already received at least one prior therapy. The European Union approved tabelecleucel for medical use in December 2022, following a positive recommendation from its Committee for Medicinal Products for Human Use. It is developed by Atara Biotherapeutics Ireland Limited.

Facts
Classification
Approval Status
Approved 1
ATC ClassSourced to the subject's own account
L: Antineoplastic and Immunomodulating Agents 2
Route of Administration
Intravenous 3
First Approved / Isolated Year
2022 1
Sources
1. Tabelecleucel (Wikipedia)
Lead section, approval-status statement
Quote, Lead section, approval-status statement
Tabelecleucel was approved for medical use in the European Union in December 2022.
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code L
Quote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
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3. Tabelecleucel (Wikipedia)
WikipediaInfobox drug, routes_of_administration
Quote, Infobox drug, routes_of_administration
Intravenous
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